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De Novo Policies Clarified In Final Guidance

A US FDA final guidance incorporates a 21st Century Cures Act provision that does away with a 30-day submission requirement for post-NSE de novo classification submissions and makes other clarifications.

US FDA's final guidance on the de novo classification process has lifted the requirement that sponsors must file a de novo request within 30 days of receiving a not substantially equivalent (NSE) determination, in accordance with provisions of the 21st Century Cures Act.

The agency recently finalized the guidance, "De Novo Classification Process (Evaluation of Automatic Class III Designation," following a six-year-plus process, including two sets of de novo program reforms from Congress....

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